Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

November 30, 2015

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

Birinapant

"Dose escalation part: (Drug escalation dose levels)~* Dose Level (1) - 13mg/m2 (twice a week for 3 of 4 weeks)~* Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks)~* Dose Level (2) - 13mg/m2 (twice weekly x 4 weeks)~* Dose Level (3a) - 17mg/m2 (twice weekly × 4 weeks)OR~* Dose Level (3b) - 17mg/m2 (twice a week for 3 of 4 weeks)"

DRUG

5-Azacitidine

Dose Level (0) - 75mg/m2 daily

Trial Locations (7)

14263

Roswell Park Cancer Institute, Buffalo

19104

University of Pennsylvania, Abramson Cancer Center, Philadelphia

32224

Mayo Clinic Jacksonville, Jacksonville

77030

The University of Texas M.D. Anderson Cancer Center, Houston

85259

Mayo Clinic Scottsdale, Scottsdale

85304

Palo Verde Hematology Oncology, Glendale

93720

California Cancer Associates for Research and Excellence, Fresno

Sponsors
All Listed Sponsors
lead

TetraLogic Pharmaceuticals

INDUSTRY

NCT01828346 - Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy | Biotech Hunter | Biotech Hunter